Edgewise Therapeutics : Sevasemten Program Update - June 26, 2025
EWTX
Published on 06/30/2025 at 15:15
June 26, 2025
Dr. Kevin Koch
Chief Executive Officer
Dr. Joanne Donovan
Chief Medical Officer
Dr. Barry Byrne
UF Health Center & Powell Gene Therapy Center
Introduction
Becker MESA Open Label Data and FDA Meeting Feedback
Duchenne Phase 2 LYNX/FOX Update and Path to Phase 3
Closing Remarks
Q & A
Sevasemten Poised to Potentially Become First Approved Therapy in Becker; Encouraging Observations in Duchenne Support Path to Phase 3
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Sevasemten Continues to Show Promise in Both Duchenne and Becker
Becker
Muscular Dystrophy
Positive observations in Becker with
continued sevasemten dosing
Positive Type C FDA meeting offers clear path to approval
GRAND CANYON on track for top-line
data 4Q26
Duchenne
Muscular Dystrophy
In LYNX & FOX, sevasemten treatment reduced the functional decline
Path to Phase 3 open with selection of 10 mg as the target dose
FDA discussion in 2H25 will refine timing
to Phase 3 start
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We Aim to Change the Lives of Individuals with Becker
PEOPLE WITH BECKER IN US, EU-5 & JAPAN
AGE PEOPLE WITH BECKER CAN BECOME MOBILITY DEVICE DEPENDENT
Bryan
Living with Becker
APPROVED THERAPIES
NOVEL MOA IN DEVELOPMENT: SEVASEMTEN
Source: Parent Project Muscular Dystrophy: Fifteen Year Registry Report; Edgewise Therapeutics independent quantitative and qualitative market research (Bluestar BioAdvisors); Edgewise research; Emery AE, Neuromuscul. Disord., 1991; MD STARnet Data and Statistics; Duchenne muscular dystrophy. National Center for Advancing Translational Sciences; Duan D et al., Nat. Rev. Dis. Primers, 2021
Edgewise is Positioned to Deliver the First Ever Therapy for Individuals with Becker Muscular Dystrophy
Sevasemten continues to demonstrate a favorable safety profile after up to three years of treatment
New open-label data demonstrates sustained disease stabilization, reinforcing prior
ARCH and CANYON findings
Natural history modeling reveals sevasemten significantly altered disease trajectory
FDA Type C meeting provides clear path to sevasemten registration, with the potential to accelerate timing to Becker launch
GRAND CANYON on track for top-line data in 4Q26 with 175 participants recruited and powered at >98% to deliver a statistically significant difference in NSAA vs placebo
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Disclaimer
Edgewise Therapeutics Inc. published this content on June 30, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on June 30, 2025 at 19:14 UTC.